SarcopeniaPSSMARNCT02679742

Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

A study testing β-hydroxymethylbutyrate in people with Sarcopenia, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Sarcopenia
What is being tested?: β-hydroxymethylbutyrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteSpain
Study dates: 1 Mar 2017to 6 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

male or female ≥60 years old
sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
being discharged from post-acute care geriatric unit for rehabilitation treatment
ambulatory prior to the recent acute process
cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)
voluntary participation and being able and willing to provide an informed consent

Who cannot join

potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
major lower limb surgery over the past 6 months (knee or hip arthroplasty)
contraindication for resistance training
performed regular exercise in the last 6 months
use of any medications interfering with the nutritional intervention
serious clinical conditions that compromises and endanger the patient's life
contraindication, intolerance or allergy to β-hydroxymethylbutyrate

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital de l'Esperanza
Barcelona, 09024

Other trials in Spain

About this study

Official title: The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)

Read the detailed description

Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function.

The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance.

Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.

Conditions: Sarcopenia
Being tested: β-hydroxymethylbutyrate, Placebo
Keywords: beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute
Medical subject headings: Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

β-hydroxymethylbutyrateDietary supplement
β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
PlaceboDietary supplement
Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Study groups in NCT02679742
Study group	Role	What they receive
β-hydroxymethylbutyrate	Experimental	β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program Receives: Dietary Supplement: β-hydroxymethylbutyrate
Placebo	Placebo comparator	Maltodextrin 3 grams once a day combined with a resistance training program Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline handgrip strength at 12 weeks
Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg
Measured: From baseline till 12 weeks
Change from baseline physical performance-gait speed- at 12 weeks
Physical performance will be assessed with gait speed in the 4-m walk test
Measured: From baseline till 12 weeks
Change from baseline physical performance-SPPB- at 12 weeks
Physical performance will be assessed with gait speed in short physical performance battery
Measured: From baseline till 12 weeks

Secondary outcomes (7)

Number of hospital readmissions
Admissions in acute care due to medical health issues
Measured: From baseline till 12 weeks
Change from baseline functional status at 12 weeks
Functional status assessed by the Barthel index
Measured: From baseline till 12 weeks
Absolute functional gain in 12 weeks
Absolute functional gain measured with Barthel scale
Measured: From baseline till 12 weeks
Relative functional gain in 12 weeks
Relative functional gain measured with Barthel scale
Measured: From baseline till 12 weeks
Change from baseline rehabilitation impact indices at 12 weeks
Rehabilitation Efficiency Index
Measured: From baseline till 12 weeks
Number of adverse events
Adverse events will be collected by medical interview during the study
Measured: From baseline till 12 weeks
Change from baseline lean and fat body mass (muscle mass) at 12 weeks
Lean and fat body mass will be measured by electrical impedance measured in kg and expressed as normal, low or high values according to normality values for the European population
Measured: From baseline till 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20176 Feb 2021

First posted10 Feb 2016 (estimated)
Study start1 Mar 2017
Primary completion6 Feb 2021
Study completion6 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for SarcopeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679742
Sponsor's protocol ID: PSSMAR 2015/6288/I
Acronym: PSSMAR
Status last verified: Apr 2020
First submitted: 26 Jan 2016
Last updated: 10 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sanchez-Rodriguez D, Marco E, Ronquillo-Moreno N, Miralles R, Mojal S, Vazquez-Ibar O, Escalada F, Muniesa JM. The PSSMAR study. Postacute sarcopenia: Supplementation with beta-hydroxyMethylbutyrate after resistance training: Study protocol of a randomized, double-blind controlled trial. Maturitas. 2016 Dec;94:117-124. doi: 10.1016/j.maturitas.2016.08.019. Epub 2016 Sep 9. No abstract available.
PubMed 27823730
Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyere O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31.
PubMed 32737844
Sanchez-Rodriguez D, Marco E, Miralles R, Guillen-Sola A, Vazquez-Ibar O, Escalada F, Muniesa JM. Does gait speed contribute to sarcopenia case-finding in a postacute rehabilitation setting? Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):176-81. doi: 10.1016/j.archger.2015.05.008. Epub 2015 May 29.
PubMed 26051706
Sanchez-Rodriguez D, Marco E, Miralles R, Fayos M, Mojal S, Alvarado M, Vazquez-Ibar O, Escalada F, Muniesa JM. Sarcopenia, physical rehabilitation and functional outcomes of patients in a subacute geriatric care unit. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):39-43. doi: 10.1016/j.archger.2014.02.009. Epub 2014 Mar 1.
PubMed 24726179
Sanchez-Rodriguez D, Marco E, Cruz-Jentoft AJ. Defining sarcopenia: some caveats and challenges. Curr Opin Clin Nutr Metab Care. 2020 Mar;23(2):127-132. doi: 10.1097/MCO.0000000000000621.
PubMed 31789867
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z.
PubMed 31233072
Meza-Valderrama D, Sanchez-Rodriguez D, Messaggi-Sartor M, Munoz-Redondo E, Morgado-Perez A, Tejero-Sanchez M, De Jaime-Gil E, Leiva-Banuelos N, Marco E. Supplementation with beta-hydroxy-beta-methylbutyrate after resistance training in post-acute care patients with sarcopenia: A randomized, double-blind placebo-controlled trial. Arch Gerontol Geriatr. 2024 Apr;119:105323. doi: 10.1016/j.archger.2023.105323. Epub 2023 Dec 27.
PubMed 38171034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sarcopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)
ClinicalTrials.gov ID: NCT02679742
Acronym / sponsor ID: PSSMAR / PSSMAR 2015/6288/I
Conditions: Sarcopenia
Keywords: beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Parc de Salut MarUniversity, hospital or other
Study start: 1 Mar 2017 (actual)
Primary completion: 6 Feb 2021 (actual)
Study completion: 6 Feb 2021 (actual)
First posted: 10 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
β-hydroxymethylbutyrate	Experimental	Dietary Supplement: β-hydroxymethylbutyrateβ-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program
Placebo	Placebo comparator	Dietary Supplement: PlaceboMaltodextrin 3 grams once a day combined with a resistance training program

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

male or female ≥60 years old
sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
being discharged from post-acute care geriatric unit for rehabilitation treatment
ambulatory prior to the recent acute process
cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)

Key exclusion criteria (7 listed)

potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
major lower limb surgery over the past 6 months (knee or hip arthroplasty)
contraindication for resistance training
performed regular exercise in the last 6 months
use of any medications interfering with the nutritional intervention

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
β-hydroxymethylbutyrateβ-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks	Dietary supplement	β-hydroxymethylbutyrate
PlaceboMaltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks	Dietary supplement	Placebo

Primary outcome

Change from baseline handgrip strength at 12 weeks
Time frame: From baseline till 12 weeks
Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg
Change from baseline physical performance-gait speed- at 12 weeks
Time frame: From baseline till 12 weeks
Physical performance will be assessed with gait speed in the 4-m walk test
Change from baseline physical performance-SPPB- at 12 weeks
Time frame: From baseline till 12 weeks
Physical performance will be assessed with gait speed in short physical performance battery

7 secondary outcomes

Number of hospital readmissions
Time frame: From baseline till 12 weeks
Change from baseline functional status at 12 weeks
Time frame: From baseline till 12 weeks
Absolute functional gain in 12 weeks
Time frame: From baseline till 12 weeks
Relative functional gain in 12 weeks
Time frame: From baseline till 12 weeks
Change from baseline rehabilitation impact indices at 12 weeks
Time frame: From baseline till 12 weeks
Number of adverse events
Time frame: From baseline till 12 weeks
Change from baseline lean and fat body mass (muscle mass) at 12 weeks
Time frame: From baseline till 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Background: PubMed 27823730Sanchez-Rodriguez D, Marco E, Ronquillo-Moreno N, Miralles R, Mojal S, Vazquez-Ibar O, Escalada F, Muniesa JM. The PSSMAR study. Postacute sarcopenia: Supplementation with beta-hydroxyMethylbutyrate after resistance training: Study protocol of a randomized, double-blind controlled trial. Maturitas. 2016 Dec;94:117-124. doi: 10.1016/j.maturitas.2016.08.019. Epub 2016 Sep 9. No abstract available.
Background: PubMed 32737844Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyere O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31.
Background: PubMed 26051706Sanchez-Rodriguez D, Marco E, Miralles R, Guillen-Sola A, Vazquez-Ibar O, Escalada F, Muniesa JM. Does gait speed contribute to sarcopenia case-finding in a postacute rehabilitation setting? Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):176-81. doi: 10.1016/j.archger.2015.05.008. Epub 2015 May 29.
Background: PubMed 24726179Sanchez-Rodriguez D, Marco E, Miralles R, Fayos M, Mojal S, Alvarado M, Vazquez-Ibar O, Escalada F, Muniesa JM. Sarcopenia, physical rehabilitation and functional outcomes of patients in a subacute geriatric care unit. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):39-43. doi: 10.1016/j.archger.2014.02.009. Epub 2014 Mar 1.
Background: PubMed 31789867Sanchez-Rodriguez D, Marco E, Cruz-Jentoft AJ. Defining sarcopenia: some caveats and challenges. Curr Opin Clin Nutr Metab Care. 2020 Mar;23(2):127-132. doi: 10.1097/MCO.0000000000000621.
Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Background: PubMed 31233072Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z.
Derived from this study: PubMed 38171034Meza-Valderrama D, Sanchez-Rodriguez D, Messaggi-Sartor M, Munoz-Redondo E, Morgado-Perez A, Tejero-Sanchez M, De Jaime-Gil E, Leiva-Banuelos N, Marco E. Supplementation with beta-hydroxy-beta-methylbutyrate after resistance training in post-acute care patients with sarcopenia: A randomized, double-blind placebo-controlled trial. Arch Gerontol Geriatr. 2024 Apr;119:105323. doi: 10.1016/j.archger.2023.105323. Epub 2023 Dec 27.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria Dolores Sánchez-Rodríguez, PhD, MD principal investigator

Parc de Salut Mar

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing β-hydroxymethylbutyrate in people with Sarcopenia, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline handgrip strength at 12 weeks (time frame: From baseline till 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02679742, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.